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August 2, 2019

FDA clears Voluntis’ Oleena app to manage cancer symptoms

Digital therapeutics firm Voluntis has received US Food and Drug Administration (FDA) clearance to market its digital app, Oleena, enabling cancer patients to self-manage symptoms.

Digital therapeutics firm Voluntis has received US Food and Drug Administration (FDA) clearance to market its digital app, Oleena, enabling cancer patients to self-manage symptoms.

The software, a Class II medical device, also facilitates remote patient monitoring.

Oleena features clinical algorithms that offer real-time personalised insights and actionable recommendations for patients to manage their own symptoms.

In addition to individualised coaching, the recommendations include on-demand instructions for initiation and dosing of supportive therapies based on a patient’s treatment plan set by their care team.

Self-management is expected to help patients avoid distressing symptoms such as diarrhoea, pain, and nausea which can affect their daily functioning and lead to treatment interruptions.

Together with remote monitoring by care teams, it is intended to cut unnecessary emergency room visits and hospitalisations, improve care and clinical outcomes, and minimise cost burden for health systems.

Oleena is also meant to assist patients across a variety of cancers and anti-cancer therapies such as chemotherapy, immunotherapy and targeted therapies.

Voluntis CEO Pierre Leurent said: “Beyond monitoring their symptoms, we believe that empowering patients via the digital delivery of real-time and personalised therapeutic interventions offers the opportunity for significant clinical and economic outcomes.

“We are delighted to introduce Oleena, the first prescription digital therapeutic in oncology, to transform patients’ experience throughout their cancer journey.”

Oleena is powered by the company’s software platform, Theraxium Oncology. All Voluntis’ oncology digital therapeutics are based on this platform.

Theraxium Oncology is designed to allow data analytics and remote maintenance of digital therapeutics.

In March, Roche Pharma France terminated its alliance with Voluntis for the development of a similar symptom management digital therapeutic called ZEMY for breast cancer patients.

The companies signed an agreement in October 2015 to develop and distribute ZEMY.

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